Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description

REF 154224 Oxford Fixed Bearing Partial Knee
Cemented Lateral Tibia
Size D6 ARCOM UHMWPE / CO-CR-MO Alloy
Only for use in Lateral compartment
Sterile R
The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Recall Number

Z-1713-2013

Classification

Class II

Code Info

M632930 , M539420 , M444860 , M657010, M987630 , M987320

Product Distributed Qty

26

Reason For Recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.